1. The Secret Life of S88 (S88 as Seen by Users)
S88 As We (Users) See It
3/31/2017
The Secret Life of S88 (S88 as Seen by Users)
Jim Parshall
Eli Lilly and Company
James H. Parshall

2. Contents Interpreting S88 S88 Business Challenges The Future
S88 As We (Users) See It
3/31/2017
Contents
Interpreting
S88
S88 Business
Challenges
The Future
The Secret Life of S88
April 18, 2000
James H. Parshall

3. Needs for Interpreting S88
S88 As We (Users) See It
3/31/2017
Needs for Interpreting S88
Standards serve countless companies in many different industries
Must be written to cover the broadest ground
Nature of standards prevents lengthy examples or interpretation details
S88.01 is not a compliance standard
It makes suggestions or provides examples
It does not list requirements
The term “S88-compliant” does not make sense.
“S88-aware” or “S88-consistent” would appear to be more appropriate.
The Secret Life of S88
April 18, 2000
James H. Parshall

4. Reasons to Form SP88 No universal model existed for batch control
S88 As We (Users) See It
3/31/2017
Reasons to Form SP88
No universal model existed for batch control
Users had a very difficult time communicating their batch processing requirements
Engineers found it very hard to integrate solutions from different vendors
Engineers and users had a difficult time configuring batch control solutions
All of these problems led to expensive batch control systems that often did not meet all of the needs of the users and were difficult to maintain.
So the S88 Committee put together a roadmap that outlined a two-part standard. Part 1, S88.01, is about models and terminology, and part 2, S88.02, is about data structures and guidelines for languages.
S88.01 was released on October 23, As of today, S88.02 has not been released.
The Secret Life of S88
April 18, 2000
James H. Parshall

5. S88 As We (Users) See It
3/31/2017
Spirit of S88
S88 isn’t just a standard for software, equipment, or procedures
It’s a way of thinking, a design philosophy
Understanding S88 will help you better design your processes and manufacture your products
S88 works with all
levels of automation
Identify your needs better.
Make recipe development easier.
Help reduce the time it takes to reach full production levels with a new system or for each new product.
S88 a framework of terminology and methodology for modular batch automation.
The Secret Life of S88
April 18, 2000
James H. Parshall

6. S88 As We (Users) See It
3/31/2017
How Does S88 Help?
1. Modularity allows for easier global replication and better return on investment
2. Isolates equipment from recipes
3. Design concepts make validation easier
4. S88-aware solutions help track product and process data
5. Gathering requirements from customers and conveying requirements to vendors is easier
6. Provides guidelines on how to recover from abnormal events
Benefit from the replication of recipes and equipment control code. Can duplicate equipment functionality with minimal changes, significantly reducing time needed to implement subsequent projects.
Good S88 design will allow validation of procedures and equipment independently.
Documenting/validating such a system is also tough. Makes recipes difficult, if not impossible, to maintain. If recipes are kept at a higher level they are more flexible. The person who knows what process changes are required -scientists, process engineers, or lead operators- can make the changes directly.
When there is a problem with a product, can be difficult to understand what was being done in the process at a given time. S88 software tracks the state of the batch in a log that can be integrated with a data historian or warehouse.
Since common terminology and models help us know what questions to ask, S88 helps better define the manufacturing process.
Working with more than one vendor is also easier. If everyone follows S88, we are much more likely to have better success integrating products from different vendors. In the long term, as vendors become more comfortable with S88, we should experience quicker turnaround time on systems and projects.
Recovering from abnormal events is one of the most difficult parts of batch control. In many non-S88 installations, automatic recovery is not implemented and operators and/or engineers are needed to get equipment and the recipe back in sync.
The Secret Life of S88
April 18, 2000
James H. Parshall

7. Improved Batch Process Metrics
S88 As We (Users) See It
3/31/2017
Improved Batch Process Metrics
Throughput
Cost
Reduced batch cycle time
Increased production rate
Faster changeover time
More scheduled recipes
Reduced downtime
Faster process development time
Faster new product launches
Reduced raw material loss
Improved batch consistency
Better equipment utilization
Less time to add or modify recipes
Lower engineering cost
Lower data capture cost
Better data availability
These benefits existed prior to S88.
Lower cost of capturing data, including less time to record batch data
Data availability is better: A larger quantity of higher-quality data is accessible for analysis
The Secret Life of S88
April 18, 2000
James H. Parshall

8. Successful Batch Control Defines These Elements
S88 As We (Users) See It
3/31/2017
Successful Batch Control Defines These Elements
Instructions on how to make a product (recipes)
The physical tools needed to make a product (equipment entities)
Methods to link recipes to equipment entities (control activities)
The Secret Life of S88
April 18, 2000
James H. Parshall

9. A Recipe Make Toothpaste Make Paste Make Gel Swirl Prepare Tank Add
S88 As We (Users) See It
3/31/2017
A Recipe
Phases are the workhorses.
Other levels simply group,
organize, and direct phases.
Make
Toothpaste
Procedure
Unit
Procedures
Make Paste
Make Gel
Swirl
Prepare
Tank
Add
Ingredients
React
Operations
Add Water
Add Fillers
Add NaF
Phases
The Secret Life of S88
April 18, 2000
James H. Parshall

10. An Example Process Cell
S88 As We (Users) See It
3/31/2017
An Example Process Cell
Material Charging
Material Selection
Pressure Control
Process
Cell
Mix FT M
Unit PT
Temperature Control TT
Discharge
and
Recirc
Equipment
Module
Control
Module
Pump FT
The Secret Life of S88
April 18, 2000
James H. Parshall

11. Interpretation of a Unit
S88 As We (Users) See It
3/31/2017
Interpretation of a Unit
Process
Cell
Unit
Equipment
Module
Control
Module
Batching cannot occur without units; batching occurs in units
A unit runs a recipe to
Combine ingredients
Perform a reaction
Add value to your product or interim product
Don’t narrow your definition of a unit to just a vessel
In-line mixer
Pasteurizer
Pasteurizers are typically three-section plate heat exchangers, and they can be large enough to hold hundreds of gallons of mix at any one time as part of a continuous process.
Even so, we really didn’t consider our pasteurizer to be a vessel. Whether or not you might think of a pasteurizer as a reactor, it certainly adds value to the product. After all, what real market value is there for unpasteurized ice cream? (Well, to pathologists, physicians, and lawyers there might be a lot of market value to unpasteurized ice cream.)
Starting, running, and stopping a pasteurizer are no trivial tasks. Using a recipe to operate a pasteurizer is certainly valid, even though the “running” portion of the recipe is active much longer than the “starting” or “stopping” portions.
The Secret Life of S88
April 18, 2000
James H. Parshall

12. What is a Unit? Not a Unit A Unit Mix making batch tank 4 Pasteurizer
S88 As We (Users) See It
3/31/2017
What is a Unit?
Not a Unit
A Unit
Mix making batch tank 4
Pasteurizer 4
Reactor 4
Pump 4
Ingredient storage tank 4
Washing machine 4
A dishwasher is a great example of a unit since it more or less runs a recipe, and we consider cleaning dishes and silverware as adding value. (If you disagree, that’s fine; but please don’t invite us over for dinner.)
Kitchen blender 4
Refrigerator 4
Dishwasher 4
The Secret Life of S88
April 18, 2000
James H. Parshall

13. What is the Scope of a Unit?
S88 As We (Users) See It
3/31/2017
What is the Scope of a Unit?
Applying the S88 concept is much easier when equipment dedicated to a single unit is considered part of the unit
If a dedicated unit resource is not permanently associated with the unit, a lot of unneeded overhead is involved to use it
Material Charging
Material Selection
Pressure Control
Mix FT
Examples include agitators, inlet or outlet valves, and instrumentation
It is probably best to keep equipment not dedicated to a single unit separate or to include it as part of an equipment or control module. M
Temperature Control PT TT
Discharge
and
Recirc
Pump FT
The Secret Life of S88
April 18, 2000
James H. Parshall

14. Equipment and Control Modules
S88 As We (Users) See It
3/31/2017
Equipment and Control Modules
Process
Cell
Unit
Equipment
Module
Control
Module
Equipment modules group devices for performing one or more specific processing activities
Control modules “connect” software to the process through actuators and sensors with all elements treated as a single entity
Equipment modules run portions of a recipe; control modules do not
Material Charging Equipment Module FT
Material Selection Control Module
The Secret Life of S88
April 18, 2000
James H. Parshall

15. Physical Model is Collapsible
S88 As We (Users) See It
3/31/2017
Physical Model is Collapsible
Process
Cell
A control module does not have to be part of an equipment module to be part of a unit
A unit can “own” control modules directly
A process cell must contain at least one unit
Unit
Equipment
Module
Control
Module
The Secret Life of S88
April 18, 2000
James H. Parshall

16. Contents Interpreting S88 Interpreting S88 S88 Business Challenges
S88 As We (Users) See It
3/31/2017
Contents
Interpreting
S88
Interpreting
S88
S88 Business
Challenges
S88 Business
Challenges
The Future
The Secret Life of S88
April 18, 2000
James H. Parshall

17. S88 As We (Users) See It
3/31/2017
Packaged Systems
In bulk chemical operations, equipment entities (tanks, valves, pumps, etc.) are combined and integrated with control systems
S88 works well when end-user assembles stainless steel and integrates to form a working system
The application of S88 has been much more focused on these type of operations
The Secret Life of S88
April 18, 2000
James H. Parshall

18. S88 As We (Users) See It
3/31/2017
Packaged Systems
Fill/finish-type operations found in the consumer products industries can benefit greatly from S88
Equipment from these operations are typically purchased from various OEMs
Integration into a common S88 framework is difficult
A single piece of equipment (an ice cream freezer, freeze dryer), often considered a unit, needs to be integrated with other equipment (pint filler, tablet compression machine) to make the best use of S88 concepts
The Secret Life of S88
April 18, 2000
James H. Parshall

19. What Do We Do?
Spec out equipment phases and have integrator or “system OEM” link equipment entities via recipes?
A two-tier S88-aware architecture
How about using S88.02 functions?
S88 software links recipes to equipment control at a level other than phase
S88 solution providers educate, assist, and influence OEMs to follow an S88 methodology
The Secret Life of S88
April 18, 2000

20. Contract Manufacturing
S88 As We (Users) See It
3/31/2017
Contract Manufacturing
Interpretation of supply chain is changing
Contract manufacturing organizations (CMO) are growing and evolving
Used in food industry for years
Concept fairly new in pharmaceuticals
Product “owners” may evolve into R&D and marketing organizations
Manufacturing will evolve to third-parties
Sales already partly transforming to third-parties
Some pharmaceutical companies now use contract employees to augment their sales forces
The Secret Life of S88
April 18, 2000
James H. Parshall

21. Contract Manufacturing
S88 As We (Users) See It
3/31/2017
Contract Manufacturing
Product “owners” will deal with general and site recipes
Product manufacturers will deal with master and control recipes
Properly transforming a general recipe into a master recipe will become even more critical
The Secret Life of S88
April 18, 2000
James H. Parshall

22. Contents Interpreting S88 S88 Business Challenges S88 Business
S88 As We (Users) See It
3/31/2017
Contents
Interpreting
S88
S88 Business
Challenges
S88 Business
Challenges
The Future
The Future
The Secret Life of S88
April 18, 2000
James H. Parshall

23. S88 Beyond Manufacturing
Theme park rides/attractions/shows
Instead of making a product according to some recipe, people are being entertained according to some sequence
Anyone visited Alien Encounter at Disney’s Magic Kingdom?
Power generation
Thinking of power in batches does not seem to make sense, but state-based procedural control could be an asset to a power plant
Moving baggage at an airport
The Secret Life of S88
April 18, 2000

24. S88 As We (Users) See It
3/31/2017
Final Thoughts
S88 being a standard with international influence is a big selling point
Make sure your vendors are aware of S88
Don’t underestimate the benefits of making your operator’s lives better
Make the process better
Don’t trash the old system just yet
You may always have to sell S88 - even after projects are complete
An S88 solution is one element in a total system of manufacturing
Eliminating unnecessary paperwork or automating a manual process frees operators up for more important and value-added tasks. Our operators hated paperwork and the manual keying of data. When we eliminated some of it, they loved us even more. If you're in a union environment, you may have some specific challenges to overcome when eliminating tasks, but sell hard. Ben & Jerry's never, ever considered firing or laying off someone just because we could eliminate a job or a portion of a job, so our operators were easy to work with on these productivity improvements. For us, improving our operators' (our customers') work lives was what excited us the most. About two weeks after successfully starting our system, we attended a conference. Since we had left the "old" batch control system in place, we told our operators that if the new system failed while we were gone, just go back to using the old system until we return. They paid us the highest possible compliment by replying, "But we don't want to use the old system.”
Don’t just look at this from a technical standpoint; realize the business side of this statement as well. Two of the biggest business challenges that manufacturing companies face today are successfully planning production and conforming to the plan. The fallout from handling these activities poorly includes missed shipment dates and underutilizing plant resources, which results in second-rate customer service metrics and higher manufacturing costs. A prerequisite to good production planning and conforming to the plan is a solid production execution. Irrespective of good production planning software or well-trained employees, inherent variability in your processes can create havoc. S88 techniques and solutions can help reduce the variability in your batching operations, allowing you to better predict the time and resources needed to execute an order.
The Secret Life of S88
April 18, 2000
James H. Parshall

25. Thank You